Kornimate/medical-research-clean huggingface dataset:
characterizing hypoxic apnea intra-individual repeatability

Conditions: Hypoxia; Apnea

Summary: apneas (breath-holds) are increasingly being tested in human subjects to understand how the human body operates. apneas decrease heart rate and increase blood pressure. these findings are driving current research into the effects of oxygen concentrations on the heart rate and blood pressure responses to apneas and the effect of breath-hold training on these responses. the interest in apnea research is three-fold: 1. apneas are a nervous system stressor that can help researchers better understand the fundamental operation of the human body; 2. elite divers can use findings from research to better their training and performance; and 3. the scientific understanding of apneas may translate to a better understanding of sleep apnea. despite this interest, little is known about the repeatability (the consistency within a single day) and reproducibility (the consistency between days) in the heart rate and blood pressure responses to apneas. this uncertainty limits the scientific interpretations from previous results. this study aims to determine the repeatability and reproducibility of heart rate and blood pressure responses to apneas. the goals of the study are: 1. to provide greater certainty to previous results; and 2. inform best practices for future studies. the study requires 20 healthy volunteers (10 females) and will measure heart rate, blood pressure, breathing parameters (expired gas concentrations, breathing volume and rate), and oxygen saturation. during the protocol, participants will complete two maximal voluntary apneas and five test apneas. the test apneas will all be the same length based on the longer of the two maximal voluntary apneas. before each apnea, participants will also breathe low oxygen concentrations (hypoxia). hypoxia provides a bigger decrease in heart rate during apneas than room air which makes it easier to see changes in heart rate responses between apneas (i.e., bigger signal-to-noise ratio). participants will complete two identical test sessions on back-to-back days. the differences in heart rate and blood pressure responses to the five apneas within each session will determine repeatability and the differences between sessions will determine reproducibility. the investigators hypothesize that repeatability will be good and that repeatability within a session will be better than reproducibility between sessions.


Eligibility criteria:
inclusion criteria: * males and females between the ages of 18-70 exclusion criteria: * having known cardiovascular or nervous system disease * low or high blood pressure (\ 139/85, respectively) * taking any prescribed medications (other than oral contraceptives) that may affect cardiovascular system function * females who may be pregnant (self-reported) * involved in other studies

Keywords: repeatability reproducibility heart rate
personalized voice activated wellness assistants for patients with heart failure

Conditions: Heart Failure; Congestive Heart Failure

Summary: the alexa+ study will compare the use of the amazon echo dot with alexa voice technology in patients with chronic heart failure to those receiving standard of care heart failure management on changes in health and patient-centered outcomes.

integrating data from virtual voice activated assistants (amazon echo dot with alexa voice technology), with the rich medical history available in electronic health records (ehr) will allow a truly customized, interactive, and automated personal healthcare assistant. this technology will be validated in patients who have chronic heart failure (hf). half of the study patients will receive an amazon echo dot (alexa) enhanced with a hf care custom alexa skill that is patient-specific, or alexa+. data on patient interactions with the device will be followed for three months. the control groups will receive standard of care (soc) hf management. both study and control groups will receive regular follow up from the hf nurse and data from all hospital or clinic visits will be captured from the ehr.

Eligibility criteria:
inclusion criteria: * heart failure patients seen at the medstar heart failure clinic and the medstar washington hospital center inpatient heart failure service * at least 18 years of age * have access to in-home wi-fi exclusion criteria: * participation in another interventional clinical trial

Keywords: clinical trial patient-centered outcomes treatment of heart failure technology in heart failure
virtual assistant for covid-19 ppe

Conditions: COVID-19

Summary: the covid virus is acquired through droplet and micro droplet transmission. although healthcare workers must adhere to strict up-to-date clinical procedures to minimize exposure to the virus and avoid contamination, the assumption that everyone can precisely remember every step is improbable as many of these procedures are quite complex and involve multiple steps in stressful situations. further the use of a trained safety officer to ensure adherence is not always feasible due to the ever growing demand of healthcare providers. investigators propose to utilize the amazon alexa device and alexa skills application to develop a voice enabled virtual assistant to guide healthcare professionals through the exact steps of clinical procedures including the donning and doffing of ppe, intubation and extubation procedures. methods a total of 10 staff anesthesiologists will be recruited to participate in phase 1 of the study to evaluate the utility and functionality of this va device. a total of 40 healthcare professionals will be recruited to participate in phase 2 of the study. anesthesia providers (staff and fellows), anesthesia assistants, respiratory assistants and operating room nurses will be randomized to receive instructional guidance by the va on one test occasion and a human coach on another occasion. during this phase of the study, the effectiveness of this va prototype will be compared with a trained human safety officer / coach in its ability to provide instructional guidance for 4 safety and clinical procedures: 1) proper donning of personal protective equipment (ppe); 2) doffing of ppe; 3) intubation (putting in a breathing tube) and 4) extubation (taking out a breathing tube).


Eligibility criteria:
inclusion criteria: * only anesthesia attending staff are allowed in the phase 1 study. * any working anesthesia staff and fellow, anesthesia assistant, respiratory assistant and operating room nurse are qualified to take part in phase 2 of this study. however, only anesthesia staff and fellows and anesthesia assistants will participate in the part that involves intubation and extubation. exclusion criteria: • unwillingness to enter the study for phase 1 or phase 2.

Keywords: ppe adherence
efficacy of pre-sleep or post-exercise protein during 12 weeks of resistance exercise training

Conditions: Aging

Summary: the goal of this clinical trial is to compare the effects of protein consumption before sleep or immediately after exercise during 12 weeks of resistance exercise training in older adults. the main questions it aims to answer are: are there differences in muscle growth or strength during 12 weeks of resistance training when 40 grams of protein is consumed either before sleep or immediately after exercise? are there differences in cognitive performance during 12 weeks of resistance training when 40 grams of protein is consumed either before sleep or immediately after exercise? this study is a randomized double-blind placebo-controlled study. participants will be randomly allocated into 1 of 3 groups. all three groups will perform the same 12-week resistance exercise training program two times per week and consume 40 g of protein: 1) immediately post-exercise, 2) 30 minutes prior to sleep, or 3) no supplemental protein (control). test of muscle growth and strength, and cognitive performance will be measure before, during, and after the exercise training program. researchers will compare the 3 conditions to determine if consume protein after exercise or before sleep during 12 weeks of resistance exercise training affects muscle growth and strength, and cognitive performance.


Eligibility criteria:
inclusion criteria: * male between 60-75 years old at the time of enrollment. exclusion criteria: * diagnosis of cardiac or peripheral vascular disease * stroke, kidney dysfunction * metabolic disease * uncontrolled hypertension * orthopedic limitations * skeletal muscle complications * milk allergy * psychiatric conditions * use of psychotropic drugs * cognitive impairment (scoring 26 points or less on the montreal cognitive assessment) * participation in a structured regular exercise program within the past 6 months * actively attempting to increase or decrease body mass * body mass index (bmi) of ≥ 35 kg/m2

Keywords: exercise hypertrophy strength power
stomaplasty ring (koringtm) for prevention of parastomal hernia

Conditions: Parastomal Hernia

Summary: parastomal hernia (psh) is one of the most frequent stoma complications with a high impact on patients' quality of life. half of the stomas created each year are permanent and up to 50% of the patients will develop a psh. psh rates depend on the type of ostomy, ileo- or colostomy. end colostomy carries the highest risk for psh (48%). psh lead to recurrent pain, poor fitting appliance with leakage and therefore, skin irritation, and can also be complicated by strangulation or occlusion. the literature reports that 30% of patients with a psh will require surgery. there are many different surgical procedures to repair psh: primary fascia repair, relocation of the stoma or repair with various type of mesh. despite the efforts done to improve the techniques, the incidence of recurrent psh is up to 70% dependent of the used technique. therefore, the idea of implanting a mesh at the time of initial stoma formation has lately been advocated. a new device, the koringkm, which is a stomaplasty ring made of propylene, flexible and non-absorbable, was created. this study will try to prove that incorporation of the new stomaplasty ring at the time of stoma creation will diminish long-term psh rate. this hypothesis will improve patient's quality of life and reduce costs associated with psh. all patients requiring a permanent ostomy (ileostomy or colostomy) for a malignant disease and fulfilling the inclusion criteria are eligible to participate in the trial. the patients will be randomized 24 to 48 hours prior to surgery after given written informed consent. the implantation of the koring will be perfomed by experienced surgeons (expertise based, best team approach) who have already implanted the koring (e.g. participated in the observational study) and/or have reviewed the video documentation. the surgeon will fill out the first form with the data of the patient and of the surgical procedure. the surgical wound will be daily examined. a second form will be fill out during the 30 post-operative days visit. the patients will be asked to inform the surgeon and/or investigator if any side event or suspicion of infection occurs after hospital discharge. the next follow-up visits will be at one and two years including a clinical examination and an abdominal ct. at this moment, the 3rd and 4th forms will be documented. all data will be anonymised and included in an excel database.


Eligibility criteria:
inclusion criteria: * patients requiring permanent ostomy (ileo- or colostomy) for a malignant tumour with at least one year life expectancy * patient is able to cooperate * patient has given written informed consent * age equal or greater than 18 years exclusion criteria: * life expectancy \< 1 year * palliative surgery * benign disease * factors impacting on the ability to cooperate * mental disorders * pregnant or breastfeeding women * participation in another intervention trial with interference of intervention and outcome of this study * bmi \< 18

Keywords: parastomal hernia prevention stomaplasty ring
nutrition and exercise program for elderly colorectal cancer patients

Conditions: Colorectal Cancer

Summary: the goal of this interventional study is to evaluate the effect of mobile health intervention on frailty, physical fitness, physical activity, and nutritional status of elderly patients with colorectal cancer. the main questions it aim to answer are: 1. does the mobile health intervention reduce frailty in elderly colorectal cancer patients compared to standard care? 2. does the mobile health intervention improve physical fitness, physical activity, and nutritional status in elderly colorectal cancer patients compared to standard care? participants will receive the mobile health management frailty care program.


Eligibility criteria:
inclusion criteria: * patients diagnosed with colorectal cancer confirmed by a physician. * aged 60 and above. * have communication skills, able to read and write or converse in mandarin and taiwanese. * clear consciousness and no mental or cognitive impairment. * physical activities are accessible. * those who have a smartphone and have experience using smartphones. exclusion criteria: * people who have difficulty walking or standing. * the wrist is not suitable for those wearing sports bracelets. * people in infectious or protective isolation. * those who live alone or in institutions.

Keywords: older colorectal cancer frailty mobile health physical activity nutrition
study of diquafosol tetrasodium ophthalmic solution in subjects with dry eye disease

Conditions: Dry Eye Disease

Summary: the purpose of this trial is to assess the effectiveness and safety of 2% diquafosol tetrasodium ophthalmic solution versus placebo following 6 weeks of treatment in subjects with mild to moderate dry eye disease.


Eligibility criteria:
inclusion criteria: * best corrected visual acuity in both eyes of at least +0.7 * six-month documented history of dry eye disease * as least mild severity in 1 of the 5 dry eye symptoms * corneal fluorescein staining of greater than or equal to 3 and less than or equal to 6 (out of 15) exclusion criteria: * permanent conjunctival goblet cell loss or scarring conditions * ongoing contact lens wear * current topical ophthalmic medication use
short-term outcomes of laparoscopic repair of paravaginal defects

Conditions: Prolapse, Vaginal; Paravaginal Cystocele

Summary: this study designed to evaluate the efficacy and outcomes of laparoscopic approach for repair of paravaginal defects associated with anterior vaginal wall prolapse.

this prospective interventional study. designed to evaluate the efficacy and outcomes of laparoscopic approach for repair of paravaginal defects associated with anterior vaginal wall prolapse .fifty participants with cystocele of lateral type offered laparoscopic paravaginal repair. the investigator used a 10mm laparoscope, with video camera, was introduced through the umbilical trocar. another 5 mm in suprapubic area and two 10 mm trocars in right and left lateral abdominal sides were introduced. the larger trocar was needed to accommodate the passage of needles into the abdomen. spacing of trocars sufficiently from each other was needed to facilitate laparoscopic suturing. transperitoneal approach to retropubic space was used. two to four polypropylene sutures were applied on each side. sutures were tied with intracorporeal . the study evaluated the following outcomes operative time, intra-operative blood loss, hospital stay , post-operative urinary symptoms, post-operative pain, fever, haematuria, post-operative vaginal wall prolapse .

Eligibility criteria:
inclusion criteria: * female patient with cystocele of lateral type ( paravaginal defect ) exclusion criteria: * previous retropubic surgery, * uterine prolapse, * stress urinary incontinence or * morbid obesity
near-infrared spectroscopy and cranial doppler in premature newborns with anemia

Conditions: Anemia of Prematurity

Summary: it is aimed in this study to examine the changes in brain blood supply and oxygenation in neonatal premature babies who have anemia and who underwent erythrocyte suspension transfusion in the light of original guidelines by means of obtaining measurements with the help of cranial doppler ultrasonography and near-infrared spectroscopy.

anemia in newborn babies is defined as the mean of hemoglobin values according to postnatal age is below 2 standard deviations. disruption in tissue perfusion and oxygenation, hyperdynamic cardiac failure, increase in need of oxygen, increase in respiratory effort, inability to be separated from mechanical ventilation, failure to thrive, paleness, increase in frequency of morbidities of prematurity (necrotizing enterocolitis, retinopathy of prematurity, intraventricular hemorrhage, etc.) may be seen as a result of progressive anemia. when critical hemoglobin values are reached in premature newborn babies with concomitant disruption of tissue oxygenation, transfusion is performed with erythrocyte suspensions. the main goal here is to correct impaired tissue oxygenation, provide perfusion in sufficient quantity, and prevent anemia-related morbidities. although frequently applied, there is no consensus in our country and in the world regarding threshold hemoglobin values and supporting parameters for transfusions. as a result, there are no guidelines prepared for newborns based on evidence with clearly defined borders and accepted by everyone. many countries and centers implement different transfusion protocols based on their experience. given the risk of oxygen radical damage and associated diseases as a result of erythrocyte transfusions (infections, bone marrow suppression, necrotizing enterocolitis, retinopathy of prematurity, etc.), there is a need to develop new methods for taking and supporting transfusion decision, and to prepare more objective and more accepted guidelines. the origin of our study is the subsequent protective compensation mechanisms after deterioration in brain oxygenation due to symptomatic anemia in premature newborn babies. for these reasons, it is aimed to examine the changes in brain blood supply and oxygenation in neonatal premature babies who have anemia and who underwent erythrocyte suspension transfusion in the light of original guidelines by means of obtaining measurements with the help of cranial doppler ultrasonography and near-infrared spectroscopy.

Eligibility criteria:
inclusion criteria: premature babies less than 32 gestational weeks or less than 1500 grams of birth weight and documented anemia in postnatal 28 days according to turkish neonatal society guidelines exclusion criteria: babies older than postnatal 28 days major congenital anomalies chromosomal anomalies inborn errors of metabolism hypoxic ischemic encephalopathy disseminated intravascular coagulation unstable hemodynamic status severe neonatal sepsis patients who are not volunteered to participate

Keywords: newborn anemia near-infrared spectroscopy cranial doppler ultrasonography
the lighthouse tenofovir cohort study

Conditions: Chronic Renal Disease

Summary: lighthouse, in cooperation with the university heidelberg public health institute and the university köln (cologne) would like to set up a cohort to study baseline characteristics and long-term clinical outcomes of patients using tenofovir based antiretroviral therapy at the lighthouse. as of march 2014, patients above 18 years and giving informed consent coming to the lighthouse to newly initiate art will be approached to enroll in the cohort. the results will be disseminated both nationally at the ministry of health technical working group (twg), at the annual research dissemination and best practices conferences of the college of medicine and national aids commission as well as internationally. the results will also be written up for publication in appropriate peer-reviewed journals.

the proposed observational cohort study will lead to improved identification of patients with virological failure and adverse drug effects, improved identification of relevant co-morbidities and result in better individual management. more importantly however, the results will allow estimates for the proportion of the described complications in the overall malawian treatment cohort. this claim can be exemplified by the retrospective analysis of patients at the lighthouse who were switched from the new 5a regimen to 6 a regimen as a result of adverse effects of efavirenz. the aim of this study is to describe baseline clinical characteristics and long-term outcomes of patients using tenofovir based antiretroviral therapy at the lighthouse clinics. the specific objectives are outlined below: objective 1: to determine the prevalence of renal dysfunction at enrolment and during follow-up among adult hiv-infected individuals starting art. objective 2: to determine the prevalence of hepatitis b virus (hbv) and hepatitis c virus (hcv) infections among adult hiv-infected individuals starting art and during treatment follow-up. objective 3: to determine the prevalence of non-communicable co-morbidities during treatment follow-up of hiv-infected individuals starting artand during treatment follow-up. the study will take place at the lighthouse, a tertiary referral art centre, with over 25,000 patients, in lilongwe, malawi. considering the study cost and power to detect a prevalence of 22% for renal impairment, we expect to have a convenience sample size of at least 850 patients at the end of three year follow-up period. the current retention at three years is almost 56%. using this retention, we will therefore enrol almost 1,500 patients starting art.

Eligibility criteria:
inclusion criteria: * 18 years or older * able and willing to give informed consent